Access to Hygiene in Patients With Dental Implants Using Two Toothbrushes

Oral Hygiene Access in Patients With Dental Implants Using Two Toothbrushes: A Randomized Crossover Clinical Trial

Peri-implant mucositis is a reversible inflammatory condition primarily caused by biofilm accumulation around dental implants. Effective plaque control is essential for disease resolution; however, the influence of toothbrush bristle design on plaque removal around implant-supported prostheses remains unclear. Polybutylene terephthalate (PBT) tapered-end bristles are more flexible than conventional medium-textured bristles and may improve access to peri-implant areas while increasing patient comfort. This study aims to compare the effectiveness of a PBT tapered-end toothbrush and a medium-textured toothbrush in plaque removal, peri-implant bacterial load reduction, and patient-reported outcomes in individuals with peri-implant mucositis. Each participant will use both toothbrushes in a randomized sequence separated by a six-week washout period. Visible plaque will be disclosed and quantified using standardized photographic analysis based on the Rustogi Modified Navy Plaque Index. Absolute and relative peri-implant bacterial loads of Porphyromonas gingivalis and Fusobacterium nucleatum, together with total bacterial load, will be quantified by quantitative polymerase chain reaction. Patient satisfaction, including perceived discomfort, comfort, ease of handling and intention to use, will be assessed using visual analogue scales.

Study Overview

• Status: Completed
• Conditions: Plaque Removal; Peri Implant Mucositis
• Intervention / Treatment: Other: Plaque removal

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Odontològic Universitat de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults diagnosed with peri-implant mucositis according to the 2017 World Workshop Classification.
• Presence of a screw-retained implant-supported prosthesis comprising one to three crowns.
• Attendance at the Implant Maintenance Unit during the recruitment period.

Exclusion Criteria:

• Use of systemic antibiotics or antiseptic mouthrinses within the previous month.
• Diagnosis of peri-implant health or peri-implantitis.
• Special healthcare needs, mobility impairment, or cognitive/psychiatric disorders preventing adequate oral hygiene.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medium-textured toothbrush; Plaque removal with a medium-textured toothbrush	Other: Plaque removal; Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush
Experimental: Polybutylene terephthalate (PBT) tapered-end toothbrush; Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush	Other: Plaque removal; Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the number of plaque-stained surfaces	Inmediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction questionnaire scores	Several visual analogue scales (VAS) going from 0 to 10 points will be handled, being 10 the highest score, regarding "Discomfort", "Ease of use" and "Comfort"	Inmediately after the intervention
Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium Nucleatum		When the microbiological samples were analyzed
Total bacterial load quantified using universal 16S rDNA primers		When microbial samples were analyzed

Collaborators and Investigators

• Sponsor: Octavi Camps-Font

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2024
• Primary Completion (Actual): May 20, 2026
• Study Completion (Actual): June 10, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 42/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No